Status:
UNKNOWN
Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)
Lead Sponsor:
Stanford University
Collaborating Sponsors:
GI Supply
Conditions:
Bile Duct Stricture
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstructi...
Detailed Description
1. Fifty patients that meet all the inclusion criteria and have none of the exclusion criteria will be invited to participate in the study. 2. Initial visit: * Written informed consent will be obt...
Eligibility Criteria
Inclusion
- All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
- One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
- Expected patient survival of at least 90 days
- High likelihood of patient follow-up
- Patient is able to give a written informed consent
- Patient is willing and able to comply with the study procedures.
Exclusion
- Patients with cholangitis
- Patients with bile leak
- Pregnant patients
- Patients with any contraindication to endoscopic procedure
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- Patients with malignant biliary strictures
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01818050
Start Date
March 1 2013
End Date
March 1 2014
Last Update
April 8 2013
Active Locations (1)
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1
Stanford University Hospital
Palo Alto, California, United States, 94035